Determining the Minimum Effective Volume of Local Anesthetic for Ultrasound-guided Axillary Brachial Plexus Block

NCT01421914 | Completed DMC

• 1 other identifier: Unifesp-USG Axillary block
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to calculate the minimum effective volume of bupivacaine 0,5% with epinephrine for successful axillary brachial plexus block for hand surgery in 50% of the patients (MEV50).

Conditions

Axillary Brachial Plexus Block

Keywords

Ultrasound; Axillary block; Bupivacaine; Minimum; Volume; Minimum volume of bupivacaine 0,5%

Outcome Measures

Primary Outcomes (1)

• Determining the minimum effective volume of bupivacaine 0,5% with epinephrine For successful axillary brachial plexus block for hand surgery

  Assessment of the success of ABPB A motor function score of 2 or less on the modified Bromage scale and also a lack of thermal sensitivity and response to a pinprick in the regions of the median, ulnar, radial and musculocutaneous nerves were considered characteristics of a successful block. Moreover, the surgery should be concluded without any complementary analgesia to confirm the success of the anaesthetic procedure.

  A blinded Assistant assess sensory and motor blockade in a 5-min intervals up to 30 minutes.

Study Arms (1)

Bupivacaine 0,5%

OTHER

Single arm study

Other: Bupivacaine 0,5%

Interventions

Bupivacaine 0,5% OTHER

The study method was a step-up/step-down sequence model where the dose for following patients was determined by the outcome of the preceding block. The starting dose of bupivacaine was 5 mL per nerve. In the case of block failure, the dose was increased by 0.5 mL per nerve. Conversely, block success resulted in a reduction in dose by 0.5 mL per nerve. Each of the three nerves was treated as a separate entity. Dose adjustments were made to each nerve individually. The volume dose was increased in 0.5 mL at every 5 consecutive cases regardless of the result of the previous block in order to minimize bias occurence. A blinded assistant assessed sensory and motor blockade at 5-min intervals up to 30 min.

Bupivacaine 0,5%

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 1 and 2 adult patients scheduled for ambulatorial hand surgery were included

You may not qualify if:

• cognitive impairment,
• coagulopathy,
• allergy to bupivacaine,
• infection at the puncture site,
• body mass index \> 35 kg/m2.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04024-002, Brazil

Location

Study Officials

• Leonardo HC Ferraro, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 21, 2011
• First Posted: August 23, 2011
• Study Start: December 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: August 1, 2012
• Last Updated: November 19, 2012

Record last verified: 2012-11

Locations

BR (1)